哌唑嗪、特拉唑嗪和坦索罗辛治疗有症状良性前列腺增生的比较：一项短期开放性随机多中心研究。BPH药物治疗研究组。良性前列腺增生

Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: a short-term open, randomized multicenter study. BPH Medical Therapy Study Group. Benign prostatic hyperplasia.

作者信息

Tsujii T

机构信息

Department of Urology, Tokyo Medical and Dental University School of Medicine, Japan.

出版信息

Int J Urol. 2000 Jun;7(6):199-205. doi: 10.1046/j.1442-2042.2000.00175.x.

DOI:10.1046/j.1442-2042.2000.00175.x

PMID:10843450

Abstract

BACKGROUND

The objective of this open randomized clinical study was to compare the short-term efficacy and safety of three alpha-1 blockers, prazosin, terazosin and tamsulosin, in the treatment of lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

METHODS

The study comprised 121 patients with symptomatic BPH who were randomized to receive 0.5 mg of prazosin twice daily, 0.5 mg of terazosin twice daily or 0.1 mg of tamsulosin once daily for the initial 2 weeks. The doses were doubled for the next 2 weeks. The primary variables assessed were a symptom score, changes in maximum and average urinary flow rate (Qmax and Qave), postvoid residual urine volume and blood pressure.

RESULTS

The percentage changes in the total symptom score from baseline were 38, 39 and 26% at 4 weeks by prazosin, terazosin and tamsulosin, respectively. Terazosin produced significantly higher improvement in four out of nine individual symptoms than tamsulosin (P < 0.05). A significant increase in Qmax or Qave in uroflowmetry was obtained in the prazosin and tamsulosin groups. Blood pressure remained unchanged in normotensive patients, but significantly decreased in hypertensive patients except for the tamsulosin group. Adverse events were minimal in all treatment groups.

CONCLUSIONS

The efficacy and safety profiles were different among the alpha-1 blockers at standard doses. Tamsulosin appears to be safer than the others for aged patients or patients with hypertension who have impaired blood pressure regulation, while terazosin is significantly effective in improving symptomatic score when compared with the others examined. It is recommended that the alpha-1 blocking agent and its optimal dose are selected on the basis of the baseline characteristics of the patients with symptomatic BPH.

摘要

背景

这项开放性随机临床研究的目的是比较三种α-1阻滞剂（哌唑嗪、特拉唑嗪和坦索罗辛）治疗良性前列腺增生（BPH）相关下尿路症状（LUTS）的短期疗效和安全性。

方法

该研究纳入了121例有症状的BPH患者，随机分为三组，分别在最初2周每日两次服用0.5mg哌唑嗪、每日两次服用0.5mg特拉唑嗪或每日一次服用0.1mg坦索罗辛。接下来的2周将剂量加倍。评估的主要变量包括症状评分、最大和平均尿流率（Qmax和Qave）的变化、排尿后残余尿量和血压。

结果

4周时，哌唑嗪、特拉唑嗪和坦索罗辛组的总症状评分相对于基线的变化百分比分别为38%、39%和26%。特拉唑嗪在九项个体症状中的四项上产生的改善明显高于坦索罗辛（P<0.05）。哌唑嗪组和坦索罗辛组的尿流率测定中Qmax或Qave显著增加。血压在血压正常的患者中保持不变，但在高血压患者中除坦索罗辛组外均显著下降。所有治疗组的不良事件均很少。